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Gut Health Response to Dietary Fiber

NCT ID: NCT01321736

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.

Detailed Description

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Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.

Conditions

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Dietary Fiber

Keywords

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dietary fiber enteral nutrition laxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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dietary fiber

mixture of fiber sources added to liquid nutrition product

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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mixed fibers include fructans, soluble fiber, and insoluble fiber

Eligibility Criteria

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Inclusion Criteria

1.Weight

* BMI between 23 - 29
* having obtained his/her informed consent
* willing and able to exclusively consume enteral diets for two 14 day periods
* willing and able to collect stool samples as instructed

Exclusion Criteria

* any disease
* use of medication except for contraceptive medication and certain OTC medications not affecting laxation
* smoking
* excessive exercise (\> 2 hours per week)
* consumption of more than 20 grams of dietary fiber daily
* pregnancy or lactation
* use of laxatives
* use of antibiotics in past 6 months
* use of pre or probiotics supplements in the past 2 months
* use of probiotic foods in the past month
* subjects who cannot be expected to comply with the study procedures
* currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* known allergy or sensitivity to formula ingredients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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Koecher KJ, Thomas W, Slavin JL. Healthy subjects experience bowel changes on enteral diets: addition of a fiber blend attenuates stool weight and gut bacteria decreases without changes in gas. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):337-43. doi: 10.1177/0148607113510523. Epub 2013 Nov 14.

Reference Type DERIVED
PMID: 24233256 (View on PubMed)

Other Identifiers

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1103M96878

Identifier Type: -

Identifier Source: org_study_id